Pacifiers, occasionally called soothers or conforters, are well known. Pacifiers generally include a pliable nipple or teat which extends from one side of a guard or shield. The guard is usually made from relatively hard plastic, compared to the nipple, and is contoured to comfortably fit against the area adjacent a baby's mouth. The diameter of the guard is of sufficient magnitude to prevent it from wholly entering the child's mouth. Oftentimes a ring or handle extends from the side of the guard opposite from the nipple.
Pacifiers are used for a variety of purposes. As suggested by the name, pacifiers soothe or "pacify" an infant by providing an oral stimulation or distraction. They also aid in the infant's digestive and waste elimination processes, by stimulating salivation and peristalsis of the bowel. It has also been reported that babies provided with pacifiers are subjected to less stress, as measured by heart rate and breathing during painful medical procedures, e.g., blood sample drawing. Infants who suck a pacifier during blood drawing also seem to cry less. Also, it seems that babies who use pacifiers during gavage feeding gain more weight more quickly than babies without pacifiers. As a result, premature infants who use pacifiers spend less time in the intensive-care units and have lower hospital costs. Finally, appropriate use of a pacifier exercises the sucking muscles which are needed for bottle and breast feeding.
While the pacifier of the present invention can be used for infants generally, it is particularly intended for premature infants, or "preemies". Premature infants are generally defined as those which are 36 weeks old or younger and usually 2,000 grams or less. Due to their immaturity and diminutive stature, premature infants have special needs. For example, they are often incapable of eating normally, at least initially.
Depending on the premature infant's age, weight and development state, it may be necessary to initially feed him intravenously, using a Dexrose-based solution. Intravenous (IV) feeding is necessary up until the time the child's digestive system is sufficiently well developed to absorb enough calories to support the child's dynamic metabolism and at the same time promote growth and weight gain. Generally, IV feeding is indicated for preemies which are younger than about 34 weeks gestation.
While IV feeding may be necessary for a time, typically 1-3 days, it is imperative to utilize an infant's normal digestive process as soon as possible. The sooner a child is capable of digesting food, the sooner it can begin eating normally. An intermediate step between IV feeding and normal sucking and swallowing is gavage tube feeding. This method involves supplying a milk-based formula directly to the infant's stomach through a feeding tube which is threaded through the mouth and down the esophagus to the stomach. A bottle or bag of formula is attached to the upper end of the gavage tube. The formula slowly courses through the gavage tube directly into the infant's stomach.
Gavage tube feeding is considered superior to IV feeding because it involves the normal digestion of a nutritionally complete formula, and is a natural step toward normal eating. There are several disadvantages associated with gavage tube feeding, however. The gavage tube must be fed through the child's oropharynx and esophagus every time the child is fed. At best, this process can cause discomfort and gagging. At worst, the gavage feeding tube can be inadvertently inserted into the infant's trachea and lungs. If feeding solution is fed into a child's lungs, the infant can literally asphyxiate. But probably the major drawback of gavage tube feeding is that it bypasses normal sucking. The infant's sucking muscles are not exercised since food is fed directly to his stomach. Sucking is important because it encourages the production of saliva and digestive juices, which help digest the infant's food, and sucking also reinforces peristalsis of the bowel.
A gavage tube also precludes or significantly interferes with the use of traditional pacifiers. If a care giver wishes to provide the infant with a traditional pacifier and a gavage tube is in place, the gavage tube must first be removed.
Before an infant can progress from gavage tube feeding to normal breast or bottle feeding, it must be capable of "constructively" sucking and swallowing. Many premature infants are not capable of constructively sucking, at least initially. An infant is "constructively" sucking if it is actually creating a considerable negative pressure in its oral cavity or oropharynx. Such negative pressure must be produced in order to draw from a bottle or breast. It is difficult to tell whether an infant is constructively sucking merely by observing the infant's mouth and cheek movements while he is using a traditional pacifier. In fact, it has heretofore been effectively impossible to determine whether an infant is truly capable of constructively sucking without repeatedly providing it with a bottle or breast. Even if an infant is orally manipulating a traditional pacifier with what appears to be a normal sucking motion, in fact the infant may simply be "playing" with the pacifier rather than constructively sucking it. This may necessitate a burdensome trial and error process involving replacing the gavage tube with a bottle and observing the infant for constructive sucking and swallowing.
The applicant, a Board-Certified pediatrician, therefore perceives that a premature infant pacifier should accommodate gavage feeding, stimulate constructive sucking and provide means for determining when an infant is ready to progress from gavage tube feeding to normal sucking and eating. Also, a preemie pacifier should be of such a size and configuration that it is suitable for use with preemies as opposed to more mature infants.
Many pacifiers have been proposed. Unfortunately, prior art pacifiers are not well suited for the premature infant. U.S. Pat. No. 4,381,785, issued to L. Robins, for example, discloses a popular type of pacifier which includes a pliable nipple and a shield which is too large for use with a premature infant and precludes simultaneous use of a gavage tube. A similar pacifier is shown in U.S. Pat. No. 4,545,378, issued to A. Chrones. In addition, some prior art pacifiers include complex structures and functions which are impractical at best and hazardous at worst. For example, U.S. Pat. No. 4,193,407, issued to O. Edmark, discloses a pacifier having table salt and non-toxic dye in the nipple; U.S. Pat. No. 4,554,919 discloses an electronic pacifier; and U.S. Pat. No. 4,447,164 discloses a temperature responsive pacifier which includes a liquid crystal material within the nipple portion. In addition to their other faults, such pacifiers are too large for premature infants, and are not at all compatible with gavage tube feeding. Nor do such pacifiers provide any indication that the child is "constructively" sucking and ready to progress from gavage tube feeding to normal sucking. U.S. Pat. No. 2,824,561, issued to Mueller, discloses a combination infant pacifier and feeding device having a hollow, nipple-shaped body which can be connected at one end to a feeding bag and which can be sucked at its opposite nipple-shaped end. While this design might seem to be capable of accommodating simultaneous feeding and pacifying, clearly the child must be capable of normal feeding before this nipple can be used. An infant incapable of normal eating must use an IV tube or gavage tube, and use of the Mueller pacifier would be impossible.
Also, some care providers have used modified feeding nipples as pacifiers for premature infants. The feeding nipple is plugged with a cotton pledgelet and then the base of the nipple is sealed with a piece of tape to hold the cotton in place. Unfortunately, there may be some risk involved in using modified feeding nipples as pacifiers. In any event, such modified nipples still interfere with use of a gavage tube and make it difficult to tell whether an infant is constructively sucking.
The present invention addresses the problems associated with prior art pacifiers. In particular, the present invention is directed toward a safe, specifically-configured pacifier for the premature infant. A preferred pacifier according to the present invention accommodates gavage tube feeding and also indicates the presence of constructive sucking so that the care provider knows when to switch from gavage tube to normal bottle or breast feeding.